Web-based Cognitive Behavioral Treatment for Insomnia in Dementia

Status Recruiting

Clinical Trial Summary

Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia. Objectives 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. 2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Dementia
Insomnia Chronic
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT04632628
Study type	Interventional
Source	University of South Florida
Contact	Christina S McCrae
Phone	573-882-0982
Email	mccraec@health.missouri.edu
Status	Recruiting
Phase	N/A
Start date	January 2, 2022
Completion date	March 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05686486` - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes	N/A
Terminated	`NCT05451693` - Outreach-ER: A Dementia Care Intervention Program
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Enrolling by invitation	`NCT06040294` - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills	N/A
Completed	`NCT05114187` - An Internet-Based Education Program for Care Partners of People Living With Dementia	N/A
Recruiting	`NCT06322121` - Vascular Aspects in Dementia: Part 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT04426838` - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad	N/A
Recruiting	`NCT03462485` - Pilot Study of the Effects of Playing Golf on People With Dementia	N/A
Active, not recruiting	`NCT03677284` - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia	N/A
Completed	`NCT03849937` - Changing Talk Online (CHATO) Study	N/A
Recruiting	`NCT06284213` - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting	`NCT05579236` - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT05080777` - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems	N/A
Completed	`NCT04571697` - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed	`NCT03583879` - Using Gait Robotics to Improve Symptoms of Parkinson's Disease	N/A
Recruiting	`NCT06033066` - Financial Incentives and Recruitment to the APT Webstudy	N/A
Active, not recruiting	`NCT05204940` - Longitudinal Observational Biomarker Study
Recruiting	`NCT05684783` - Dementia Champions in Homecare
Completed	`NCT03147222` - Function Focused Care: Fracture Care at Home	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers — NiteCAPP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms